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RS Kumar,1 Manish Kumar Jain,2 Jitendra Singh Kushwaha,3 Santosh Patil,4 Vasanti Patil,5 Soumya Ghatak,6 Jayesh Sanmukhani,7 Ravindra Mittal7 1Department of Pulmonary Medicine, Government Medical College & Government General Hospital, Srikakulam, India; 2Department of Pulmonary Medicine, Maharaja Agrasen Superspeciality Hospital, Jaipur, India; 3Department of Medicine, Prakhar Hospital Pvt. Ltd, Kanpur, India; 4Department of ENT, Jeevan Rekha Hospital, Belgavi, India; 5Department of ENT, Rajarshi Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital, Kolhapur, India; 6Department of ENT, College of Medicine and Sagore Dutta Hospital, Kolkata, India; 7Department of Clinical Research and Regulatory Affairs, Cadila Healthcare Limited, Ahmedabad, IndiaCorrespondence: Jayesh Sanmukhani, Department of Clinical Research and Regulatory Affairs, Cadila Healthcare Ltd, Ahmedabad, India, Tel +91 76000 12192, Email Jayesh_sanmukhani@yahoo.co.in; jayeshsanmukhani@zyduscadila.comObjective: To compare the efficacy and safety of a fixed dose combination of Fluticasone Furoate and Oxymetazoline Hydrochloride Nasal Spray 27.5/50 mcg (FDC) with Fluticasone Furoate Nasal Spray 27.5 mcg (Fluticasone) in the management of allergic rhinitis.Patients and Methods: A prospective, randomized, double-blind, two-arm, active-controlled, parallel, multicenter, comparative clinical study was conducted in patients with allergic rhinitis aged 18 years and above having moderate-to-severe nasal congestion.Results: A total of 250 patients were randomized (1:1) to receive either the FDC or Fluticasone alone in a dose of two sprays in each nostril once daily at night. There was a significantly (P< 0.001) greater reduction in night-time Total Nasal Symptom Score with the FDC as compared to Fluticasone at all the time points starting from as early as day 3 and sustained till the end of treatment (Day 28) (Day 3: − 3.1 vs − 2.2; Day 7: − 4.0 vs − 3.4; Day 14: − 5.7 vs − 5.0; Day 28: − 7.0 vs − 6.4). A significantly ...